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NCT ID: NCT01455675 Completed - Cystic Fibrosis Clinical Trials

Efficacy Study of IgY (Antibody Against Pseudomonas) in Cystic Fibrosis Patients

PsAer-IgY
Start date: October 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to prolong the time to reinfection with Pseudomonas aeruginosa after successfully treated acute or intermittent infection.

NCT ID: NCT01455545 Completed - Asthma Clinical Trials

Impact of Adherence to Treatment in Asthma Control

Start date: January 2011
Phase: N/A
Study type: Observational

This survey aims to analyze how adherence to treatment, using Ask-20 questionnaire and prescription count, influences level of asthma control in a sample of patients with severe and moderate-mild asthma.

NCT ID: NCT01455051 Completed - Clinical trials for Chronic Lymphocytic Leukemia

Ofatumumab as Part of Reduced Intensity Conditioning (RIC) Regimen for Patients With High Risk Chronic Lymphocytic Leukemia (CLL) Undergoing Allogeneic Hematopoietic Cell Transplantation

Start date: October 2011
Phase: Phase 2
Study type: Interventional

A good proportion of patients with chronic lymphocytic leukemia (CLL) can be managed effectively with palliative chemotherapy. However, there is a group of younger patients with poor risk disease whose life expectancy is significantly reduced. As a result, reduced intensity conditioning (RIC) allogeneic hematopoietic cell transplantation (allo-HCT) has been investigated as a potentially curative procedure. Recently, the European Group for Blood and Marrow Transplantation (EBMT) published a set of guidelines suggesting situations where allo-HCT might be considered a therapeutic option for CLL patients. Their conclusions were that allo-HCT was reasonable for younger CLL patients refractory to fludarabine, relapsing within two years of intensive treatment, or with p53 abnormalities requiring treatment. However, the results with RIC allo-HCT are not entirely satisfactory, and progression-free survival after allo-HCT revolves around 35-40% at 3-5 years following allo-HCT. This is due to non-relapse mortality, which is significantly associated with the development of graft-versus-host disease (GVHD), but also due to disease relapse. These relapses may occur early in the course of the transplantation, like any other hematological malignancy, but late relapses have also been reported. Several strategies have been tested in order to improve these results. The anti-CD20 monoclonal antibody rituximab, given concomitantly with allo-HCT or donor lymphocyte infusions, may reduce graft-versus-host disease and facilitate disease control. This may be due, not only to direct cytotoxicity, but also to modulation of GVHD and the graft-versus CLL effect (GVCLL). Interestingly, rituximab has been shown to promote the cross-presentation of tumor-derived peptides by antigen-presenting cells, thus enhancing the formation of cytotoxic T-cell clones and a GVCLL effect. With the addition of rituximab to the conditioning regimen, rates at 4 years for current progression-free survival (CPFS) and overall survival were 44% and 48%. The investigators hypothesize that ofatumumab, having a more potent anti-CLL activity and complement-dependent cytoxicity than rituximab, could improve disease control and modulate the GVCLL effect more effectively, thus reducing the GVHD rate and subsequently improving the non-relapse mortality and progression-free survival in the long term.

NCT ID: NCT01454934 Completed - Clinical trials for Non-Small Cell Lung Cancer (NSCLC)

A Randomized, Open-label, Multicenter, Phase 3 Study to Compare the Efficacy and Safety of Eribulin With Treatment of Physician's Choice in Subjects With Advanced Non-Small Cell Lung Cancer

Start date: December 9, 2011
Phase: Phase 3
Study type: Interventional

This is a randomized, open-label, multicenter, Phase 3 study, comparing efficacy and safety of eribulin with TPC in subjects with advanced and disease progression following at least two prior regimens for advanced disease, which should have included a platinum-based regimen.

NCT ID: NCT01454739 Completed - Hemophilia A Clinical Trials

Long-Term Safety and Efficacy of rFVIIIFc in the Prevention and Treatment of Bleeding Episodes in Previously Treated Participants With Hemophilia A

ASPIRE
Start date: December 2011
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to evaluate the long-term safety of recombinant human Factor VIII Fc fusion protein (rFVIIIFc) in participants with hemophilia A. The secondary objective of the study is to evaluate the efficacy of rFVIIIFc in the prevention and treatment of bleeding episodes in participants with hemophilia A.

NCT ID: NCT01454531 Completed - Clinical trials for Allergic Rhinoconjunctivitis

An Open Trial to Assess the Tolerability of AVANZ Phleum Pratense Immunotherapy

Start date: June 2011
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to assess the tolerability of AVANZ.

NCT ID: NCT01454323 Completed - Clinical trials for Chronic Myocardial Ischemia

Intracoronary Infusion of Bone Marrow Mononuclear Cells in Patients With Previous Myocardial Infarction.

Start date: December 2010
Phase: Phase 2
Study type: Interventional

Phase II clinical trial which will include all patients diagnosed with chronic anterior myocardial infarction (more than 6 months from the acute phase and the complete revascularization in which it is assessed the evolution of left ventricular function in patients to the monitoring against their own basal condition. Included patients will be studied in the following conditions: - Basal condition: defined as the immediately preceding to the administration of cell therapy treatment. - Monitoring Condition 1: three months after drug administration of cell therapy. Includes non-invasive methods of exploration of ventricular function. - Monitoring Condition 2: six months after administration of treatment. Includes the same methods of exploration of ventricular function practised in the basal condition, including cardiac catheterism as well as non invasive methods. - Monitoring Condition 3: twelve months after administration of the cell therapy drug. Includes non-invasive methods of exploration of ventricular function. The trial hypothesis we propose consists of mononuclear cells of bone marrow providing progenitor cells with regenerative capacity and also secreting several angiogenic factors, and their implantation into ischemic tissues should contribute with both elements to the angiogenesis and tissue regeneration with myocardial functional recovery

NCT ID: NCT01454297 Completed - Multiple Myeloma Clinical Trials

Relating Clinical Outcomes in Multiple Myeloma to Personal Assessment of Genetic Profile

CoMMpass
Start date: July 2011
Phase:
Study type: Observational

The primary objective of this observational study is to identify the molecular profiles and clinical characteristics that define subsets of myeloma patients during the course of the disease.

NCT ID: NCT01454284 Completed - Clinical trials for Diabetes Mellitus, Type 1

A Study in Participants With Type I Diabetes Mellitus

IMAGINE 3
Start date: January 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is: - To compare blood sugar control on LY2605541 with insulin glargine after 52 weeks of treatment. - To compare the rate of nocturnal low blood sugar episodes on LY2605541 with insulin glargine during 52 weeks of treatment. - To compare the number of participants on LY2605541 reaching blood sugar targets without low blood sugar episodes at night to those taking insulin glargine after 52 weeks of treatment. - To compare the rate of low blood sugar episodes on LY2605541 with insulin glargine during 52 weeks of treatment

NCT ID: NCT01454180 Completed - Clinical trials for Advanced Pancreatic Carcinoma

Study of Individualized Selection of Chemotherapy in Patients With Advanced Pancreatic Carcinoma According to Therapeutic Targets

Start date: October 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the proportion of patients alive after 12 months of the beginning of the trial in patients with advanced pancreatic carcinoma individually selected and grouped according to the expression in tumor tissue for therapeutic targets.